Informed Consent to Vaccination: Theoretical, Legal, and Empirical Insights

118 Pages Posted: 5 Feb 2019 Last revised: 7 Oct 2021

Date Written: January 20, 2019


Informed consent matters. So does protecting people from infectious diseases. This paper examines what the appropriate informed consent process for vaccines should look like and how the process is conceptualized by law and health authorities. Drawing on the extensive theoretical and empirical literature on informed consent and vaccination, the article sets out what an ideal informed consent process for vaccination would consist of, highlighting the need for autonomous decisions. To be autonomous, decisions need to be based on full, accessible information and arrived at without coercion. We suggested that the information provided must address the nature of the procedure – including benefits to the child, benefits to society, and risks. Parents should have concerns and misconceptions addressed. The information needs to be accessible, and include an opportunity to ask questions. Based on this ideal model we examined in detail the legal framework surrounding informed consent to vaccination and the process as conceptualized by health authorities in two countries, Israel and the United States, to assess whether they meet the requirements. Our countries have similarities in some of their values, for example, the importance of individual autonomy, and face similar problems related to vaccine hesitancy. At the same time, they also have meaningful differences, among other things in their vaccine policy and the current structure of the informed consent process, allowing for a meaningful comparison. We found neither country met our ideal informed consent process, and suggested improvements both to the materials and to the process used to obtain informed consent.

Keywords: Informed Consent, Vaccines, Public Health, Torts

JEL Classification: K13, K32, I18

Suggested Citation

Reiss, Dorit Rubinstein and Karako-Eyal, Nili, Informed Consent to Vaccination: Theoretical, Legal, and Empirical Insights (January 20, 2019). 45 American Journal of Law & Medicine 357 (2019), Available at SSRN: or

Dorit Rubinstein Reiss (Contact Author)

UC Law, San Francisco ( email )

200 McAllister Street
San Francisco, CA 94102
United States
415-5654844 (Phone)
415-5654865 (Fax)

Nili Karako-Eyal

College of Management (Israel) ( email )

7 Rabin Blvd.
Rishon Lezion
Tel Aviv, 75190

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